Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients

Phase 3TerminatedNCT00492388

Hospira, now a wholly owned subsidiary of Pfizer2 enrolled

Overview

To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients.

The primary objective is to evaluate the safety and efficacy following the administration of intranasal ketamine in providing pain relief as compared to placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain Cancer

Interventions

PMI-150 (intranasal ketamine)DRUG

intranasal dosing

placeboDRUG

placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * at least 18 years of age * Patients requiring around-the-clock opioids for pain due to cancer and with a history of experiencing episodes of breakthrough pain Exclusion Criteria: * under 18 years * non-cancer pain * allergy to ketamine

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

pain intensity difference

Time frame: 60 minutes

Secondary Outcomes

various pain assessments

Time frame: 60 minutes

Data from ClinicalTrials.gov

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